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  • 22nd new homegrown drug Acelex adds side effect after PMS
  • by Lee, Hye-Kyung | translator Alice Kang | May 31, 2022 06:06am
MFDS conducts reevaluations 6 years after approval¡¦label change to be made soon
Crystal Genomics¡¯ ¡®Acelex Tab (polmacoxib)¡¯ that was approved as the 22nd homegrown new drug in Korea will be adding ¡®strokes, etc¡¯ to its list of adverse events.

The Ministry of Food and Drug Safety announced that it had completed the opinion review for the Change in Acelex's Indications based on Reevaluation Results (draft) and will be reflecting the changes in the indication from August 26th.

Acelex was approved on February 5th, 2015 as an anti-inflammatory analgesic to relieve the symptoms of osteoarthritis patients. The drug was also designated the 22nd new homegrown drug to receive marketing authorization in Korea.

The drug has been supplied to large general hospitals and university hospitals thr
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